Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties, sterility, and chemical resistance of surgical gloves. There is no mention of any computational or analytical functions that would involve AI/ML.

Therapeutic

No.
The device is a surgical glove system intended to protect medical personnel and patients from contamination, not to treat a disease or condition.

Diagnostic

No

This device is a surgical glove system intended for protection against contamination and chemotherapy drugs, not for diagnosing any medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glove system made of synthetic polyisoprene rubber, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, diagnose conditions, or monitor treatment.
Device Function: The described device is a surgical glove system. Its primary function is to provide a physical barrier to protect a surgical wound from contamination and to protect the operating room personnel from potential exposure to chemotherapy drugs.
Lack of Specimen Analysis: The device does not analyze any biological specimens from a patient. It is a barrier device used during a medical procedure.
Testing for Permeation: While the device is tested for permeation by chemotherapy drugs, this testing is to assess the barrier properties of the glove, not to diagnose or provide information about a patient's health based on a specimen.

The device falls under the category of a medical device, specifically a surgical glove, but it does not meet the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove together. Please note that the following drugs have extremely low permeation times: 3.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.

Product codes (comma separated list FDA assigned to the subject device)

KGO, LZC, OPJ

Device Description

Gammex® Pl Plus Glove-in-Glove™ System tested for use with Chemotherapy Drugs is a sterile and disposable device. This glove system ismade of synthetic polyisoprene rubber. Gammex® Pl Plus Glove- in-Glove™ System Tested for Use with Chemotherapy Drugs is comprised of a single-use, sterile, white outer glove, which is a disposable, powder-free surgical glove made from synthetic polyisoprene and a single-use, sterile, green underglove which is a disposable, powder-free surgical glove made from syntheticpolyisoprene. The Gammex® Pl PlusGlove-in-Glove™ system Testedfor Use with Chemotherapy Drugs is comprised of the underglove being mechanically inserted into the outer glove prior to packing and sterilization. There is no adhesive present between the two gloves. This results in quick double gloving with only one donning event.

Gammex® PI Plus Glove™ System Tested for Use with Chemotherapy Drugs conforms to the following FDA recognized consensus standards: ASTM D3577-19, ASTM D6124-06, ASTM D5151-19, ASTM D412-16, ISO 11137-1:2006, ISO 10993-1:2018, ISO 10993-10:2010, ISO 10993-10:2010, ISO 10993-11:2017, & ASTM D6978-05.

Gammex® PI Plus Glove-in-Glove™ System Tested for Use with Chemotherapy Drugs is available in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:
Gammex® PI Plus Glove™ System Tested for Use with Chemotherapy Drugs has the following technological characteristics as compared to ASTM or equivalent standards:

ASTM D3767-03: Dimensions - PASS, Acceptance criteria in accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves
ASTM D3577-19: Physical Properties - PASS, Acceptance criteria for tensile strength, ultimate elongation and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves
ASTM D5151-19: Freedom from holes - PASS, Acceptance criteria in accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves with AQL requirements of 1.5
ASTM D6124: Powder-Free - PASS, Meets applicable acceptance criteria for powder free ≤ 2mg per glove per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves
ANSI/AAMI/ISO 11137-1:2006: Sterility - PASS, Meets acceptance criteria requirement of 10-6 SAL per ISO 11137-1: Sterilization for health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ASTM D6978-05(2019): Chemotherapy Drug Permeation Test - PASS, Acceptance Criteria in accordance with ASTM D6978-05(2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. *Please note that the following drugs have extremely low permeation times: Carmustine (35.0 min) and Thiotepa (67.0 min)
ISO 10993-5: ISO in vitro Cytotoxicity Study:
- Gammex®Non-Latex PI Surgical Glove (Outerglove): FAIL, Surfaces at undiluted and at the dilution of 1:2 was found to be cytotoxic (grade 4) to L-929 cells post 48 hour and non-cytotoxic at 1:4 dilution with grade 2 and with grade 0 at 1:8, :16, 1:32 and 1;64 dilutions. Acceptance criteria in accordance with ISO 10993-5: Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity, 2009.
- Gammex®Non-Latex PI Underglove (Underglove): FAIL, Dilutions of 1:16, 1:32, and 1:64 were found to be non-cytotoxic (grade 0). Dilution 1:8 showed moderate cytotoxicity (grade 3). Undiluted, 1:2, and 1:4 dilutions showed severe positive cytotoxicity (grade 4). Acceptance criteria in accordance with ISO 10993-5: Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity, 2009.
ISO 10993-10:2010: ISO Skin Irritation Study - PASS, Passes Primary Skin Irritation test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization. Under the conditions of the study, not an irritant.
ISO 10993-10:2010: ISO Maximization Sensitization Study - PASS, Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization. Under the conditions of the study, not a sensitizer
ISO 10993-11:2017: ISO Acute Systemic Toxicity Study – ISO10993-11:2017 - PASS, Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity. Under the conditions of the study, there was no mortality or evidence of acute systemic toxicity

Clinical Studies:
A clinical study was not conducted on the subject device.

Key results: The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K190077

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K190018

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 26, 2023

Ansell Healthcare Products, LLC Tammy McGriff Manager 2301 Robb Drive Reno, Nevada 89523

Re: K213289

Trade/Device Name: Gammex® PI Plus Glove-in-Glove System™ Tested For Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC, OPJ Dated: May 24, 2023 Received: May 26, 2023

Dear Tammy McGriff:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Allan Guan -S

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213289

Device Name

Gammex® PI Plus Glove-in-Glove™ System Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove together. Please note that the following drugs have extremely low permeation times: 3.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.

Test Chemotherapy drug & Concentration	Average Breakthrough Detection Time (Minutes)
Bleomycin - 15.0 mg/ml	>240
Busulfan - 6.0 mg/ml	>240
Carboplatin - 10 mg/ml	>240
Carmustine - 3.3 mg/ml	35.0
Cisplatin - 1.0 mg/ml	>240
Cyclophosphamide - 20.0 mg/ml	>240
Cytarabine HCl - 100.0 mg/ml	>240
Dacarbazine - 10.0 mg/ml	>240
Daunorubicin HCl - 5.0 mg/ml	>240
Docetaxel - 10.0 mg/ml	>240
Doxorubicin HCl 2.0 mg/ml	>240
Epirubicin - 2.0 mg/ml	>240
Etoposide - 20.0 mg/ml	>240
Fludarabine - 25 mg/ml	>240
Fluorouracil - 50.0 mg/ml	>240
Gemcitabine - 38.0 mg/ml	>240
Idarubicin - 1.0 mg/ml	>240
Ifosfamide - 50.0 mg/ml	>240
Irinotecan - 20.0 mg/ml	>240
Mechlorethamine HCl - 1.0 mg/ml	>240
Melphalan - 5.0 mg/ml	>240
Methotrexate - 25.0 mg/ml	>240
Mitomycin C - 0.5 mg/ml	>240
Mitoxantrone - 2.0 mg/ml	>240
Oxaliplatin - 2.0 mg/ml	>240
Paclitaxel - 6.0 mg/ml	>240
Rituximab - 10.0 mg/ml	>240
Thiotepa - 10.0 mg/ml	67.0
Vincristine Sulfate - 1.0 mg/ml	>240

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510KSummary

510(k) Number:

K213289

Submitter:

Ansell HealthcareProducts LLC. 2301 Robb Drive Reno, NV 89523

Contact Person(s):

Tammy McGriff Manager, Regulatory Affairs/Quality Assurance Phone: 334-796-9361 Email: tammy.mcgriff@ansell.com

Carson Delaloye Senior Coordinator, Regulatory Affairs Phone: 530-401-8977 Email: carson.delaloye@ansell.com

Date Prepared

May 24, 2023

Name of Device

| Trade Names: | Gammex® PI Plus Glove-in-Glove™ System Tested for Use
with Chemotherapy Drugs |
|----------------------------|----------------------------------------------------------------------------------|
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Regulation: | 21 CFR 878.4460 |
| Device Class: | I |
| Product Code: | KGO, OPJ, LZC |
| Classification Panel: | General and Plastic Surgery |

Legally Marketed Predicate Device

K190077 – Biogel® PI UltraTouch S Surgical Glove, Biogel® PI Ultra Touch SIndicator Underglove

Legally Marketed Reference Device

K190018 - Gammex® Non-Latex Pl White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs

5

Device Description

Gammex® Pl Plus Glove-in-Glove™ System tested for use with Chemotherapy Drugs is a sterile and disposable device. This glove system ismade of synthetic polyisoprene rubber. Gammex® Pl Plus Glove- in-Glove™ System Tested for Use with Chemotherapy Drugs is comprised of a single-use, sterile, white outer glove, which is a disposable, powder-free surgical glove made from synthetic polyisoprene and a single-use, sterile, green underglove which is a disposable, powder-free surgical glove made from syntheticpolyisoprene. The Gammex® Pl PlusGlove-in-Glove™ system Testedfor Use with Chemotherapy Drugs is comprised of the underglove being mechanically inserted into the outer glove prior to packing and sterilization. There is no adhesive present between the two gloves. This results in quick double gloving with only one donning event.

Gammex® PI Plus Glove™ System Tested for Use with Chemotherapy Drugs conforms to the following FDA recognized consensus standards: ASTM D3577-19, ASTM D6124-06, ASTM D5151-19, ASTM D412-16, ISO 11137-1:2006, ISO 10993-1:2018, ISO 10993-10:2010, ISO 10993-10:2010, ISO 10993-11:2017, & ASTM D6978-05.

Gammex® PI Plus Glove-in-Glove™ System Tested for Use with Chemotherapy Drugs is available in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0

Indication for Use Statement

Gammex® PI Plus Glove-in-Glove™ System Tested for Use with Chemotherapy Drugs

A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove & outer glove together. Please note that the following drugs have extremely low permeation times: Carmustine: 35.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.

| TEST CHEMOTHERAPY DRUG AND
CONCENTRATION | AVERAGEMINIMUM
BREAKTHROUGH
DETECTIONTIME
(Minutes) |
|------------------------ | Bleomycin (15.0 mg/ml) | Busulfan (6.0 mg/ml) | Carboplatin (10.0 mg/ml) | Carmustine (3.3 mg/ml) | Cisplatin (1.0 mg/ml) | Cyclophosphamide (20.0 mg/ml) | Cytarabine HCl (100.0 mg/ml) | Dacarbazine (10.0 mg/ml) | Daunorubicin HCl (5.0 mg/ml) | Docetaxel (10.0 mg/ml) | Doxorubicin HCl (2.0 mg/ml) | Epirubicin (2.0 mg/ml) | Etoposide (20.0 mg/ml) | Fludarabine (25.0 mg/ml) | Fluorouracil (50.0 mg/ml) | Gemcitabine (38.0 mg/ml) | Idarubicin (1.0 mg/ml) | Ifosfamide (50.0 mg/ml) | Irinotecan (20.0mg/ml) | Mechlorethamine HCI (1.0 mg/ml) | Melphalan (5.0mg/ml) | Methotrexate (25.0 mg/ml) | Mitomycin C (0.5 mg/ml) | Mitoxantrone (2.0mg/ml) | Oxaliplatin (2.0 mg/ml) | Paclitaxel (6.0 mg/ml) | Rituximab (10.0 mg/ml) | Thiotepa (10.0 mg/ml) | Vincristine Sulfate (1.0 mg/ml) ---------------------|--------------------------------------------------------------|
| >240 |
| >240 |
| >240 |
| 35.0 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| 67.0 |
| >240 |

Tested chemotherapy drugs are as follows:

6

7

Technological Characteristics:

	Predicate Device	Proposed Subject Device	Comparison
Trade name	Biogel® PI UlltraTouch S
Surgical Glove, Biogel® PI
Ultra Touch S Indicator
Glove	Gammex® PI Plus Glove-in-
Glove™ System Tested for
Use with Chemotherapy
Drugs	Different - New
Product
510kNumber	K190077	K213289	Different -New
510(k)
Product Owner	Mölnlycke Health Care US,
LLC	Ansell Healthcare Products
LLC	Different - Separate
Businesses
Product Code	KGO	KGO, OPJ, LZC	Different -OPJ,LZC product
codes added for chemo
Regulation
Number	21 CFR 878.4460	21 CFR 878.4460	Same
Regulatory Class	I	I	Same
Regulation
Name	Non-powdered Surgeon's
Gloves	Non-powdered Surgeon's
glove	Same
Indicationsfor
Use	The Biogel PI UltraTouch S
Surgical Glove is a disposable
device made of polyisoprene, that
is intended to be worn on the
hands, usually in a surgical
setting, to provide a barrier
against potentially infectious
material and other contaminates.
The Biogel PI UltraTouch S
Indicator Underglove is a
disposable device made of
polyisoprene, blue in color, that is
intended to be worn on the
hands, usually in a surgical
setting, to provide a barrier
against potentially infectious
material and other contaminants	A powder-free surgeons' glove is
intended to be worn by operating
room personnel to
protect a surgical wound from
contamination. The glove system
was tested for use with
Chemotherapy Drugs as per ASTM
D6978-05 Standard Practice for
Assessment of Medical Gloves to
Permeation by Chemotherapy
Drugs. Chemotherapy testing was
carried out on the system as a
whole, including both the under-
glove & outer-glove together.
Please note that the following
drugs have extremely low
permeation times: Carmustine:
35.0 minutes and Thiotepa: 67.0
minutes. Warning: Do not use with
Carmustine or Thiotepa.	Different
Material
Composition	Synthetic polyisoprene
rubber	Synthetic polyisoprene
rubber	Same
Coating	Hydrogel Polymer Coating	Polyacrylic Polymer Inner Coating	Different
Design	Single use	Single use	Same
	Powder-free	Powder-free	Same
	Hand Specific	Ambidextrous	Different
	Beaded cuff	Beaded cuff	Same
Color	Under Glove- Blue
OuterGlove-Straw (Natural)	Under Glove—Green
Outer Glove - White	Different - Changed
Color
Labeling	Surgeon's Gloves	Surgeon's Gloves	Same
Shelf Life	3 Years	No claimed shelf life	Different
	Predicate Device	Proposed Subject Device	Comparison
Performance
a. Dimensions	Meets ASTM D3577-09 (2015)
requirements	Meets ASTM D3577-19
requirements	Same
b. Physical
Properties	Meets ASTM D3577-09 (2015)
requirements	Meets ASTM D3577-19
requirements	Same
c. Freedom from
holes	Meets ASTM D3577-09 (2015)
AQL Meets CFR 800.20
Requirements	Meets ASTM D3577- 19 Gl,
AQL 1.5 Requirements	Same
d. Powder
Residual	Meet applicable definition for
powder free per ASTM
D3577-19; ≤ 2mg per glove	Meet applicable definition for
powder free per ASTM
D3577-19; ≤ 2mg per glove	Same
e. Sterility	Sterile	Sterile	Same
Biocompatibility
Skin Irritation	Passes Primary Skin Irritation test
per ISO 10993-10, Biological
Evaluation of medical devices,
Part 10: Test for irritation and
skin sensitization	Passes Primary Skin Irritation test
per ISO 10993-10, Biological
Evaluation of medical devices,
Part 10: Test for irritation and
skin sensitization	Same
Biocompatibility
Sensitization	Passes Dermal Sensitization test
per ISO 10993-10, Biological
Evaluation of medical devices,
Part 10: Test for irritation and
skin sensitization	Passes Dermal Sensitization test
per ISO 10993-10, Biological
Evaluation of medical devices,
Part 10: Test for irritation and
skin sensitization	Same
Biocompatibility
Acute Systemic
Toxicity	Passes Acute Systemic Toxicity
Test per ISO 10993-11, Biological
Evaluation of medical devices,
Part 11: Test for systemic toxicity	Passes Acute Systemic Toxicity Test
per ISO 10993-11, Biological
Evaluation of medical devices,
Part 11: Test for systemic toxicity	Same
Sterilization
Method	Gamma Irradiation	Gamma Irradiation	Same
Sterilization
Information	Meets ANSI/AAMI/ISO 11137-
1:2006
requirement of 10-6 SAL.	Meets ANSI/AAMI/ISO 11137-
1:2006
requirement of 10-6 SAL.	Same
Prescription or
Over the
counter	Over the Counter	Over the Counter	Same

Technological Characteristics Comparison Table for Predicate Device

8

9

Itemized List of Differences Between Predicate and Proposed:

Trade Name
- The difference is that the trade names are different due to the gloves being separate styles from sperate O owners. There is no impact on the safety or effectiveness with the changing of device names.
510k Number
- There are different 510k numbers because they are different owners. There is no impact o on the safety or effectiveness with the predicate and proposed having different 510ks.
Product Owner
- o There are different product owners for the proposed and predicate devices. There is no impact on safety or effectiveness with the predicate as this device has already been FDA cleared.
FDA Product Code
- The predicate device does not have chemotherapy testing so there is no OPJ or LZC product code. O
Indications for Use
- o There are different indications for use listed as the predicate device does not have chemotherapy data or indications for such use.
Coating
- The sum total of all performance safety and efficacy testing presented indicates that the proposed device is as о safe and effective as the predicate and reference device.
Design
- O The predicate device is listed as a hand specific glove, while the proposed is ambidextrous. There is no change to safety or efficacy as the gloves have different donning methods.
Color
- The predicate device is two gloves, the outer being straw colored and the under glove being blue. O
- The proposed device is two gloves, the outer being white and the under glove being green. O
- O The sum total of all performance safety and efficacy testing presented indicates that the proposed device is as safe and effective as the predicate and reference device.
Shelf Life ●
- O There is no claimed shelf life for the proposed device.

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Technological Characteristics:

	Reference Device	Proposed Subject Device	Comparison
Trade name	Gammex® Non-Latex PI
White Polyisoprene Surgical
Gloves Tested for Use with
Chemotherapy Drugs	Gammex® PI Plus Glove-in-
Glove™ System Tested for
Use with Chemotherapy
Drugs	Different - New
Product
510kNumber	K190018	K213289	Different - New
510(k)
Product Owner	Ansell Healthcare Products
LLC	Ansell Healthcare Products
LLC	Same
Product Code	KGO, OPJ	KGO, OPJ, LZC	Different -LZC added
Regulation
Number	21 CFR 878.4460	21 CFR 878.4460	Same
Regulatory Class			Same
Regulation
Name	Non-powdered Surgeon's
Gloves	Non-powdered Surgeon's
Gloves	Same
Indicationsfor
Use	Gammex Non Latex PI White
Surgical Gloves Tested for Use
with Chemotherapy Drugs are
intended to be worn by
operating room personnel to
protect a surgical wound from
contamination. These gloves
were tested for use with
Chemotherapy Drugs as per
ASTM D6978-05 Standard
Practices for Assessment of
Medical Gloves to Permeation
by Chemotherapy Drugs.	A powder-free surgeons' glove is
intended to be worn by operating
room personnel to
protect a surgical wound from
contamination. The glove
system was tested for use with
Chemotherapy Drugs as per
ASTM D6978-05 Standard
Practice for Assessment of
Medical Gloves to Permeation
by Chemotherapy Drugs.
Chemotherapy testing was
carried out on the system as a
whole, including both the
under-glove & outer-glove
together. Please note that the
following drugs have extremely
low permeation times:
Carmustine: 35.0 minutes and
Thiotepa: 67.0 minutes.
Warning: Do not use with
Carmustine or Thiotepa.	Different
Material
Composition	Synthetic polyisoprene
rubber	Synthetic polyisoprene
rubber	Same
Coating	Polyacrylic Polymer Inner
Coating	Polyacrylic Polymer Inner
Coating	Same
Design	Single use	Single use	Same
	Powder-free	Powder-free	Same
	Hand Specific	Ambidextrous	Different
	Beaded cuff	Beaded cuff	Same
Color	White	Under Glove – Green
Outer Glove - White	Different - Changed
Color
Labeling	Surgeon's Gloves	Surgeon's Gloves	Same
Shelf Life	2 Years	No claimed shelf life	Different
	Reference Device	Proposed Subject Device	Comparison
Performance
a. Dimensions	Meets ASTM D3577-09 (2015)
requirements	Meets ASTM D3577-19
requirements	Same
b. Physical
Properties	Meets ASTM D3577-09 (2015)
requirements	Meets ASTM D3577-19
requirements	Same
c. Freedom from
holes	Meets ASTM D3577- 19 GI, AQL
1.5
Requirements	Meets ASTM D3577- 19 GI, AQL
1.5
Requirements	Same
d. Powder
Residual	Meet applicable definition for
powder free per ASTM
D3577-19; $\le$ 2mg per glove	Meet applicable definition for
powder free per ASTM
D3577-19; $\le$ 2mg per glove	Same
e. Sterility	Sterile	Sterile	Same
Biocompatibility
Skin Irritation	Passes Primary Skin Irritation test
per ISO 10993-10, Biological
Evaluation of medical devices, Part
10: Test for irritation and skin
sensitization	Passes Primary Skin Irritation test
per ISO 10993-10, Biological
Evaluation of medical devices,
Part 10: Test for irritation and
skin sensitization	Same
Biocompatibility
Sensitization	Passes Dermal Sensitization test
per ISO 10993-10, Biological
Evaluation of medical devices,
Part 10: Test for irritation and
skin sensitization	Passes Dermal Sensitization test
per ISO 10993-10, Biological
Evaluation of medical devices,
Part 10: Test for irritation and
skin sensitization	Same
Biocompatibility
Acute Systemic
Toxicity	Passes Acute Systemic Toxicity
Test per ISO 10993-11, Biological
Evaluation of medical devices,
Part 11: Test for systemic toxicity	Passes Acute Systemic Toxicity Test
per ISO 10993-11, Biological
Evaluation of medical devices,
Part 11: Test for systemic toxicity	Same
Sterilization
Method	Gamma Irradiation	Gamma Irradiation	Same
Sterilization
Information	Meets ANSI/AAMI/ISO 11137-
1:2006
requirement of 10-6 SAL.	Meets ANSI/AAMI/ISO 11137-
1:2006
requirement of 10-6 SAL.	Same
Prescription or
Over the
counter	Over the Counter	Over the Counter	Same

Technological Characteristics Comparison Table for Reference Device

11

12

ltemized List of Differences Between Reference and Proposed:

. Trade Name
- o The difference is that the trade names are different due to the gloves being separate styles. There is no impact on the safety or effectiveness with the changing of device names.
. 510k Number
- o There are different 510k numbers because they are different devices. There is no impact on the safety or effectiveness with the reference and proposed having different 510ks.
. Indications for Use
- o There are different indications for use listed as the predicate device does not have chemotherapy data or indications for such use.
. Design
- O The predicate device is listed as a hand specific glove, while the proposed is ambidextrous. There is no change to safety or efficacy as the gloves have different donning methods.
. Color
- The sum total of all performance safety and efficacy testing presented indicates that the proposed device is as O safe and effective as the predicate and reference device.
. Shelf Life
- o There is no claimed shelf life for the proposed device.

13

	Predicate Device	Proposed Subject Device
Trade Name	Biogel® PI UlltraTouch S Surgical
Glove, Biogel® PI Ultra Touch S
Indicator Glove	Gammex® PI Plus Glove-in-
Glove™ System Tested for
Use with Chemotherapy
Drugs	Different
Devices
Chemotherapy
Claim	Tested chemotherapy
drugs/concentration & Average
Minimum Breakthrough
Detection Time (Minutes) are as
follows	A powder-free surgeons' glove is
intended to be worn by
operating room personnel to
protect a surgical wound from
contamination. The glove was
tested for use with
Chemotherapy Drugs as per
ASTM D6978-05 Standard
Practice for Assessment of
Medical Gloves to Permeation by
Chemotherapy Drugs.
Chemotherapy testing was
carried out on the system as a
whole, including both the under-
glove & outer glove together.
Please note that the following
drugs have extremely low
permeationtimes: Carmustine:
35.0 minutes and Thiotepa: 67.0
minutes. Warning: Do not use
with Carmustine or Thiotepa.
Tested chemotherapy
drugs/concentration
& Average Minimum
Breakthrough
Detection Time
(Minutes) are as
follows:	Different
	Not Available for Device	Busulfan (6.0 mg/ml)

240 min. | Different |
| | Not Available for Device | Carmustine (3.3 mg/ml)
35.0 | Different |
| | Not Available for Device | Cisplatin (1.0 mg/ml)
240 min. | Different |
| | Not Available for Device | Cyclophosphamide (20.0 mg/ml)
240 min. | Different |
| | Not Available for Device | Cytarabine (100.0 mg/ml)
240 min. | Different |
| Predicate Device | Proposed Subject Device | Comparison | |
| Not Available for Device | Dacarbazine (10.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Daunorubicin HCl (5.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Docetaxel (10.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Doxorubicin HCl (2.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Etoposide (20.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Fludarabine (25.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Fluorouracil (50.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Gemcitabine (38.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Idarubicin (1.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Ifosfamide (50.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Irinotecan (20.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Mechlorethamine HCl (1.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Melphalan (5.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Methotrexate (25.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Mitomycin C (0.5 mg/ml)
240 min. | Different | |
| Not Available for Device | Mitoxantrone (2.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Oxaliplatin (2.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Paclitaxel (6.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Rituximab (10.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Thiotepa (10.0 mg/ml)
67.0 | Different | |
| Not Available for Device | Vincristine Sulfate (1.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Bleomycin (15.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Carboplatin (10.0 mg/ml)
240 min. | Different | |
| Not Available for Device | Epirubicin (2.0 mg/ml)
240 min. | Different | |
| | Reference Device | Proposed Subject Device | Comparison |
| Trade Name | Gammex® Non-Latex
Polyisoprene White Surgical
Gloves Tested for Use with
Chemotherapy Drugs. | Gammex® PI Plus Glove-in-
Glove™ System Tested for
Use with Chemotherapy
Drugs | Different
Devices |
| Chemotherapy Claim | These gloves are intended to be worn
by operating personnel to
protect a surgical wound from
contamination.
These gloves were tested for use
with
Chemotherapy Drugs as per ASTM
D6978-05 Standard Practice for
Assessment of Medical Gloves to
Permeation by Chemotherapy
Drugs.
Tested chemotherapy
drugs/concentration &
Average Minimum
Breakthrough Detection Time
(Minutes) are as follows | A powder-free surgeons' glove
is intended to be worn by
operating room personnel to
protect a surgical wound from
contamination. The glove was
tested for use with
Chemotherapy Drugs as per
ASTM D6978-05 Standard
Practice for Assessment of
Medical Gloves to Permeation
by Chemotherapy Drugs.
Chemotherapy testing was
carried out on the system as a
whole, including both the
under-
glove & outer glove together.
Please note that the following
drugs have extremely low
permeationtimes: Carmustine:
35.0 minutes and Thiotepa: 67.0
minutes. Warning: Do not use
with Carmustine or Thiotepa.
Tested chemotherapy
drugs/concentratio
n & Average
Minimum
Breakthrough
Detection Time
(Minutes) are as
follows: | |
| | Busulfan (6.0 mg/ml)
240 min. | Busulfan (6.0 mg/ml)
240 min. | Same |
| | Carmustine (3.3 mg/ml)
10.2 | Carmustine (3.3 mg/ml)
35.0 | Different |
| | Cisplatin (1.0 mg/ml)
240 min. | Cisplatin (1.0 mg/ml)
240 min. | Same |
| | Cyclophosphamide (20.0 mg/ml)
240 min. | Cyclophosphamide (20.0 mg/ml)
240 min. | Same |
| | Cytarabine (100.0 mg/ml)
240 min. | Cytarabine (100.0 mg/ml)
240 min. | Same |
| | Dacarbazine (10.0 mg/ml)
240 min. | Dacarbazine (10.0 mg/ml)
240 min. | Same |
| Reference Device | Proposed Subject Device | Comparison | |
| Daunorubicin HCl (5.0 mg/ml)
240 min. | Daunorubicin HCl (5.0 mg/ml)
240 min. | Same | |
| Docetaxel (10.0 mg/ml)
240 min. | Docetaxel (10.0 mg/ml)
240 min. | Same | |
| Doxorubicin HCl (2.0 mg/ml)
240 min. | Doxorubicin HCl (2.0 mg/ml)
240 min. | Same | |
| Etoposide (20.0 mg/ml)
240 min. | Etoposide (20.0 mg/ml)
240 min. | Same | |
| Fludarabine (25.0 mg/ml)
240 min. | Fludarabine (25.0 mg/ml)
240 min. | Same | |
| Fluorouracil (50.0 mg/ml)
240 min. | Fluorouracil (50.0 mg/ml)
240 min. | Same | |
| Gemcitabine (38.0 mg/ml)
240 min. | Gemcitabine (38.0 mg/ml)
240 min. | Same | |
| Idarubicin (1.0 mg/ml)
240 min. | Idarubicin (1.0 mg/ml)
240 min. | Same | |
| Ifosfamide(50.0 mg/ml)
240 min. | Ifosfamide(50.0 mg/ml)
240 min. | Same | |
| Irinotecan (20.0 mg/ml)
240 min. | Irinotecan (20.0 mg/ml)
240 min. | Same | |
| Mechlorethamine HCl (1.0 mg/ml)
240 min. | Mechlorethamine HCl (1.0 mg/ml)
240 min. | Same | |
| Melphalan (5.0 mg/ml)
240 min. | Melphalan (5.0 mg/ml)
240 min. | Same | |
| Methotrexate (25.0 mg/ml)
240 min. | Methotrexate (25.0 mg/ml)
240 min. | Same | |
| Mitomycin C (0.5 mg/ml)
240 min. | Mitomycin C (0.5 mg/ml)
240 min. | Same | |
| Mitoxantrone (2.0 mg/ml)
240 min. | Mitoxantrone (2.0 mg/ml)
240 min. | Same | |
| Oxaliplatin (2.0 mg/ml)
240 min. | Oxaliplatin (2.0 mg/ml)
240 min. | Same | |
| Paclitaxel (6.0 mg/ml)
240 min. | Paclitaxel (6.0 mg/ml)
240 min. | Same | |
| Reference Device | Proposed Subject Device | Comparison | |
| Rituximab(10.0 mg/ml)
240 min. | Rituximab(10.0 mg/ml)
240 min. | Same | |
| Thiotepa (10.0 mg/ml)
11.5 | Thiotepa (10.0 mg/ml)
67.0 | Different | |
| Vincristine Sulfate(1.0 mg/ml)
240 min. | Vincristine Sulfate (1.0 mg/ml)
240 min. | Same | |
| Bleomycin(15.0 mg/ml)
240 min. | Bleomycin(15.0 mg/ml)
240 min. | Same | |
| Carboplatin(10.0 mg/ml)
240 min. | Carboplatin(10.0 mg/ml)
240 min. | Same | |
| Epirubicin (2.0 mg/ml)
240 min. | Epirubicin (2.0 mg/ml)
240 min. | Same | |

14

ltemized List of Chemotherapy Differences Between Predicate and Proposed:

The predicate device was not tested for use with chemotherapy drugs. The safety and efficacy of the . proposed device with respect to chemotherapy drugs is addressed through the performance testing and labeling of the device.

15

16

17

Itemized List of Chemotherapy Differences Between Reference and Proposed:

The proposed device has a longer breakthrough time for Carmustine. This show safety and efficacy as the reference . device has already been cleared with lower breakthrough times.
. The proposed device has a longer breakthrough time for This show safety and efficacy as the reference device has already been cleared with lower breakthrough times.

18

The subject device meets the applicable requirements for surgeons's gloves with regards to dimensions and sizes, physical properties, freedom from holes, and powder residues as found in the following standards: ASTM D3577, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization, and acute systemic toxicity, in accord with the ISO 10993 series of standards.

Non-Clinical Testing

Gammex® PI Plus Glove™ System Tested for Use with Chemotherapy Drugs has the following technological characteristics as compared to ASTM or equivalent standards:

Results	Title of Test	Purpose of Test
PASS	ASTM
D3767-03	Dimensions	Acceptance criteria in accordance with ASTM D3577-19: Standard
Specification for Rubber Surgical Gloves
PASS	ASTM
D3577-19	Physical Properties	Acceptance criteria for tensile strength, ultimate elongation and
stress at 500% elongation before and after accelerated aging for
synthetic surgical gloves per ASTM D3577-19 : Standard Specification
for Rubber Surgical Gloves
PASS	ASTM
D5151-19	Freedom from
holes	Acceptance criteria in accordance with ASTM D3577-19: Standard
Specification for Rubber Surgical Gloves with AQL requirements of 1.5
PASS	ASTM
D6124	Powder-Free	Meets applicable acceptance criteria for powder free ≤ 2mg per glove
per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves
PASS	ANSI/AAMI/I
SO 11137-
1:2006	Sterility	Meets acceptancecriteria requirement of 10-6 SAL per ISO 11137-1:
Sterilization for health care products – Radiation – Part 1: Requirements
for development, validation and routine control of a sterilization process
for medical devices
PASS	ASTM
D6978-
05(2019)	Chemotherapy
Drug
Permeation
Test:	Acceptance Criteria in accordance with ASTM D6978-05(2019):
Standard Practice for Assessment of Resistance of Medical Gloves to
Permeation by Chemotherapy Drugs.
*Please note that the following drugs have extremely low
permeation times: Carmustine (35.0 min) and Thiotepa (67.0 min)

19

| | ISO 10993-5 | Biocompatibility: | Gammex®Non-Latex PI Surgical
Glove (Outerglove) | Gammex®Non-Latex Pl
Underglove (Underglove) |
|------|-----------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FAIL | ISO 10993-5 | ISO in vitro
Cytotoxicity
Study | Surfaces at undiluted and at the
dilution of 1:2 was found to be
cytotoxic (grade 4) to L-929 cells
post 48 hour and non-cytotoxic at
1:4 dilution with grade 2 and with
grade 0 at 1:8, :16, 1:32 and 1;64
dilutions. Acceptance criteria in
accordance with ISO 10993-5:
Biological Evaluation of Medical
Devices, Part 5: Tests for In Vitro
Cytotoxicity, 2009. | Dilutions of 1:16, 1:32, and 1:64
were found to be non-cytotoxic
(grade 0). Dilution 1:8 showed
moderate cytotoxicity (grade 3).
Undiluted, 1:2, and 1:4 dilutions
showed severe positive
cytotoxicity (grade 4). Acceptance
criteria in accordance with ISO
10993-5: Biological Evaluation of
Medical Devices, Part 5: Tests for In
Vitro Cytotoxicity, 2009. |
| PASS | ISO 10993-
10:2010 | ISO Skin
Irritation
Study | Passes Primary Skin Irritation test per ISO 10993-10, Biological
Evaluation of medical devices, Part 10: Test for irritation and skin
sensitization. Under the conditions of the study, not an irritant. | |
| PASS | ISO 10993-
10:2010 | ISO
Maximization
Sensitization
Study | Passes Dermal Sensitization test per ISO 10993-10, Biological
Evaluation of medical devices, Part 10: Test for irritation and skin
sensitization. Under the conditions of the study, not a sensitizer | |
| PASS | ISO 10993-
11:2017 | ISOAcute Systemic
Toxicity Study –
ISO10993-11:2017 | Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological
Evaluation of medical devices, Part 11: Test for systemic toxicity.
Under the conditions of the study, there was no mortality or
evidence of acute systemic toxicity | |

Clinical Studies

A clinical study was not conducted on the subject device.

Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device.